A recent Kaiser Health Newsarticle reported that FDA sent criminal investigation agents to nine Florida stores that help patients buy prescription drugs from pharmacies in Canada.

“We have heard from thousands of our constituents about skyrocketing prescription drug prices and have proposed several bills to address this urgent problem—including by allowing for the safe importation of prescription drugs. Although the Federal Food, Drug, and Cosmetic Act prohibits the importation of unapproved drugs, the FDA has long focused its enforcement efforts on ‘products apparently intended for the commercial market and on fraudulent products, and those that pose an unreasonable health risk,’” the senators wrote. “We are concerned that the Food and Drug Administration may be taking actions to scale back the agency’s ‘non-enforcement policy’ that currently allows for limited importation of prescription drugs.”

The letter also calls on Commissioner Gottlieb to endorse Klobuchar and Senator John McCain’s (R-AZ) Safe and Affordable Drugs from Canada Act, which would amend the Federal Food, Drug, and Cosmetic Act to allow for the personal importation of prescription drugs from approved pharmacies in Canada for personal use with a valid prescription.

The letter is the latest in a continuing effort by Klobuchar and Grassley to find solutions to the ever-increasing costs of prescription medications. Earlier this year, Klobuchar and Grassley introduced the Preserve Access to Affordable Generics Act to expand consumers’ access to the cost-saving generic drugs they need and increase competition by ending “pay for delay” deals—the practice of brand-name drug companies using anti-competitive pay-off agreements to keep more affordable generic equivalents off the market. Klobuchar, Grassley, and a bipartisan group of Senators also introduced theCreating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which would address abusive tactics – like brand-name drug companies denying samples when generic companies request them – that prevent affordable drugs from entering the market.

In February, Klobuchar, Grassley, and McCain urged then- Department of Health and Human Services (HHS) Secretary Tom Price to use his statutory authority to immediately certify the importation of prescription drugs from Canada under certain circumstances to address drug price hikes or a lack of competition in the United States. They also urged Commissioner Gottlieb in June to address abuses in the regulatory process that delay competition and increase prescription drug costs and in July asked him to address anticompetitive practices currently used by some brand-name pharmaceutical companies to delay the manufacture and introduction of generic drugs in the market—issues that would be addressed by the bipartisan CREATES Act.

The full text of the senators’ letter is below.

Dear Commissioner Gottlieb:

We have heard from thousands of our constituents about skyrocketing prescription drug prices and have proposed several bills to address this urgent problem—including by allowing for the safe importation of prescription drugs. Earlier this year, we also asked the Office of Management and Budget and the Department of Health and Human Services to use existing statutory authority to allow for individuals to import prescription drugs for personal use. While we appreciate that you have acknowledged that “too many patients are being priced out of the medicines they need,” we are concerned that the Food and Drug Administration (FDA) may be taking actions to scale back the agency’s “non-enforcement policy” that currently allows for limited importation of prescription drugs.

Although the Federal Food, Drug, and Cosmetic Act prohibits the importation of unapproved drugs, the FDA has long focused its enforcement efforts on “products apparently intended for the commercial market and on fraudulent products, and those that pose an unreasonable health risk.” According to the agency’s Regulatory Procedures Manual, “FDA personnel may allow entry of shipments when the quantity and purpose are clearly for personal use, and the product does not present an unreasonable risk to the user.”This non-enforcement policy for prescription drugs with a valid prescription has been FDA’s position for many years.

We are concerned that a November 20, 2017 report by Kaiser Health News may indicate a change in this longstanding policy. The article notes that FDA sent criminal investigation agents with search warrants into nine Florida stores that help patients buy prescription drugs from pharmacies in Canada. It is our understanding that these stores solely assist patients who prefer to purchase prescription drugs from outside the United States – including by helping patients avoid websites that sell fraudulent or unsafe products – and do not dispense drugs themselves. The report states that these stores, several of which have been open for more than a decade, fear FDA’s actions reflect a decision by the Trump Administration to scale back or reverse the “non-enforcement policy.”

Additionally, Senators McCain (R-AZ) and Klobuchar (D-MN) have introduced theSafe and Affordable Drugs from Canada Act, which would amend the Federal Food, Drug, and Cosmetic Act to allow for the personal importation of prescription drugs from approved pharmacies in Canada for personal use with a valid prescription. The legislation specifically excludes controlled substances and biologics. Your endorsement of this legislation would demonstrate the FDA’s commitment to lowering prescription drug prices in this country.

Due to our concerns that the FDA actions in Florida may reflect a change in policy, we request that you respond to the following questions no later than January 5, 2018.

Has the FDA changed the policy included in the 2016 Regulatory Procedures Manual regarding personal importation of safe prescription drugs from Canada?

If so, what is the current policy?

Are there any barriers to the certification of importation of prescription drugs from Canada in the following circumstances?

a) The drug is off patent or no longer marketed in the U.S. by the innovator company that initially developed the drug;

b) Significant and unexplained increases in price;

c) No direct competitor drug is currently in the market and introduction of a competitor drug will lower the prices paid by taxpayers and consumers; or

d) The drug is produced in another country by the name brand manufacturer that initially developed the drug or by a well-known generic manufacturer that commonly sells pharmaceutical products in the U.S.